Laparoscopic versus hybrid approach for treatment of incisional ventral hernia: a prospective randomized multicenter study of 1-month follow-up results.

PURPOSE: The seroma rate following laparoscopic incisional ventral hernia repair (LIVHR) is up to 78%. LIVHR is connected to a relatively rare but dangerous complication, enterotomy, especially in cases with complex adhesiolysis. Closure of the fascial defect and extirpation of the hernia sack may reduce the risk of seromas and other hernia-site events. Our aim was to evaluate whether hybrid operation has a lower rate of the early complications compared to the standard LIVHR.
METHODS: This is a multicenter randomized-controlled clinical trial. From November 2012 to May 2015, 193 patients undergoing LIVHR for primary incisional hernia with fascial defect size from 2 to 7 cm were recruited in 11 Finnish hospitals. Patients were randomized to either a laparoscopic (LG) or to a hybrid (HG) repair group. The outcome measures were the incidence of clinically and radiologically detected seromas and their extent 1 month after surgery, peri/postoperative complications, and pain.
RESULTS: Bulging was observed by clinical evaluation in 46 (49%) LG patients and in 27 (31%) HG patients (p = 0.022). Ultrasound examination detected more seromas (67 vs. 45%, p = 0.004) and larger seromas (471 vs. 112 cm3, p = 0.025) after LG than after HG. In LG, there were 5 (5.3%) enterotomies compared to 1 (1.1%) in HG (p = 0.108). Adhesiolysis was more complex in LG than in HG (26.6 vs. 13.3%, p = 0.028). Patients in HG had higher pain scores on the first postoperative day (VAS 5.2 vs. 4.3, p = 0.019).
CONCLUSION: Closure of the fascial defect and extirpation of the hernia sack reduce seroma formation. In hybrid operations, the risk of enterotomy seems to be lower than in laparoscopic repair, which should be considered in cases with complex adhesions. CLINICAL TRIAL NUMBER: NCT02542085.

RCT Entities:   Population Interventions Outcomes